Siemens Healthineers · 2 months ago
Director - Immunoassay Commercial Product Quality (Remote)
United States
Full-time
Remote
Director/Executive
$173K/yr - $259K/yr
8+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. This role is responsible for leading the CLS Immunoassay Commercial Product Quality Team, focusing on complaint handling, product quality, and customer satisfaction while ensuring compliance with regulatory standards.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Serving as a Subject Matter Expert for post market topics, processes and tools
Ensuring compliance with applicable regulations and standards
Drive product safety, product quality, and customer satisfaction related decisions, with appropriate authority (both data-based and risk-assessment-based decisions)
Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction
On time reporting of medical device reports
Addressing FDA and other NCA concerns with product recalls to achieve the best outcome (regarding recall classification and where applicable, continued product availability)
Training and development of group members to satisfactorily complete their job activities and career aspirations
Ensuring group members have product and regulatory knowledge to perform their jobs compliantly
Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs)
Foster a culture of continuous improvement, accountability, and customer focus
Developing and supporting digitalization strategies for CPQ
IVDR Plans and Reports for associated product lines
Cross functional collaboration
Qualification
Required
Demonstrated ability to lead and manage people
Direct experience in the in-vitro diagnostics industry
Strong communication (written, oral, and listening) and problem-solving skills
Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes
Proven experience covering post market topics in front room external inspections (e.g., FDA, TUV, etc.)
Ability to balance heavy workload, customer needs, patient/operator health/safety and regulatory compliance
Strong technical knowledge of supported product lines
Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above
Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements
Experience in Quality Systems, MDRs and Field Action recommended
Advanced degree MAY be substituted for experience, where applicable
Willing to travel 20%
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
2026-01-16
Company data provided by crunchbase